E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients of both genders between 18 - 85 years of age undergoing elective surgery for a histologically confirmed solitary, non-metastatic colonic tumour and not including rectal tumours within 15cm of the anal orifice. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Effects on the biochemical and biological markers of systemic inflammation:
To assess the role of Taurolidine in the attenuation of the surgically induced systemic endotoxaemia and the subsequent pro-inflammatory cytokine response in patients with colon cancer cytokine kinetics
To assess the role of Taurolidine in the attenuation of the immune dysregulation that occurs post-operatively
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E.2.2 | Secondary objectives of the trial |
Effects on the clinical markers of systemic inflammation:
To assess the role of Taurolidine in the reduction of postoperative infectious complications as well as recurrence of tumour growth
To assess the role of Taurolidine in the reduction of post-operative pain
To assess the role of Taurolidine in the return of GI function postoperatively
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria
Patients of either gender who are 18 to 85 years of age. Patients with a solitary, non-metastatic, histologically proven colonic tumour undergoing elective surgery. Patients who gave full written informed consent with assent of next of kin Negative pregnancy test in women of childbearing age
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E.4 | Principal exclusion criteria |
Exclusion:
Rectal tumours (within 15cms of the anal orifice) Known allergy to taurolidine / taurine Pregnant and lactating women Liver disease • Abnormal LET’s (>2 times ULN) • INR > 1.5 Renal disease o Creatinine >180 (women), >150 (men) o Serum sodium <132 or >145, Blood dyscrasia • Neutropenia < 1500 cells /cm3 • Thrombocytopenia < 100,000 cells/cm3 Intestinal obstruction Infiltration of adjacent organs Tumour diameter > 8 cm on CT scan Severe obesity (body mass index >32 kg/m2), Operative risk greater than ASA - III, Another cancer / malignant disease other than non melanoma skin cancer Coexisting active inflammatory disorder (including active RA, IBD, SLE) Immunocompromised • Corticosteroids • Immunosuppressive drugs • Patients with HIV, chronic active Hepatitis B or C virus Active infection
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoints
Difference in taurolidine as compared to placebo group in the mean Ln (IL-6) levels on day 1 relative to baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |